Evaluation of Mindfulness and Yoga in Basic Combat Training

Sponsor
Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT05550610
Collaborator
U.S. Army Medical Research and Development Command (U.S. Fed), U.S. Army Training and Doctrine Command (TRADOC) (Other)
1,896
1
2
14.6
129.7

Study Details

Study Description

Brief Summary

The present study is a group randomized trial assessing the impact of mindfulness and yoga training on the health, performance, and well-being of soldiers in Basic Combat Training (BCT). Randomization occurred at the platoon level, and platoons received either a combined mindfulness and yoga regimen or training as usual.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Based Attention Training (MBAT) and Yoga
N/A

Detailed Description

This program evaluation assessed a training initiative developed and implemented by the U.S. Army Training and Doctrine Command. Four surveys were conducted with soldiers in all participating platoons over the course of BCT, and two additional surveys were administered with those soldiers in the mindfulness and yoga intervention condition. A follow-up survey was distributed to all participants 6-12 months after BCT. In addition, two surveys were conducted with BCT cadre and drill sergeants. Army data reflecting performance, attrition, and health were also obtained for analysis.

Study Design

Study Type:
Interventional
Actual Enrollment :
1896 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
group randomized trialgroup randomized trial
Masking:
None (Open Label)
Masking Description:
All participants were aware whether they were assigned to receive mindfulness and yoga or training as usual.
Primary Purpose:
Prevention
Official Title:
Evaluation of Mindfulness and Yoga in Basic Combat Training
Actual Study Start Date :
Oct 12, 2020
Actual Primary Completion Date :
Dec 16, 2020
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness and Yoga

Mindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Yoga was delivered 6 days/week, 30 minutes per day.

Behavioral: Mindfulness Based Attention Training (MBAT) and Yoga
Mindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Participants also completed 15 minutes of group mindfulness practice 6 days/week and received information on embedded practice during the duty day. Yoga was delivered 6 days/week, 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training.

No Intervention: Training as Usual

Training as usual included standard exercises 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training.

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The PHQ-2 is a validated screening tool for depression. The PHQ-2 included a single item assessing impairment in functioning attributable to reported symptoms.

  2. ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time [0-10 weeks]

    ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records

Secondary Outcome Measures

  1. Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The GAD-2 is a validated screening tool for anxiety. The GAD-2 included a single item assessing impairment in functioning attributable to reported symptoms.

  2. Insomnia Severity Index (ISI): Change Over Time [0, 3-4, 6-7, and 9-10 weeks]

    The ISI is a validated screening tool for insomnia and sleep-related problems.

  3. Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time [0, 3-4, 6-7, and 9-10 weeks]

    A single item from the PSQI was used to assess overall sleep quality.

  4. Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The DVPRS is a measure of self-reported pain designed for use in military and veteran populations. The DVPRS was adapted for the present study to assess pain-related interference with training, sleep, mood, and stress.

  5. Patient Health Questionnaire (PHQ-15): Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The PHQ-15 is a validated measure of a range of patient health outcomes. Ten items from the PHQ-15 were used to assess physical pain and assorted medical symptoms.

  6. Mental Toughness Inventory (MTI): Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The MTI is a measure of mental toughness and resilience. Eight items from the MTI were used in the present evaluation: Four items assessed mental toughness during stressful events, and four items assessed mental toughness following stressful events.

  7. Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The MAIA is a measure of interoceptive awareness and mindfulness-related constructs. Ten items from the MAIA were used in the present evaluation: Six items assessed the capacity to not self-distract, and four items assessed capacity for self-regulation.

  8. Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time [0, 3-4, 6-7, and 9-10 weeks]

    The FFMQ is a measure of engagement in mindful awareness.

  9. Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    The Brief DERS is a shortened version of a validated measure assessing ability to manage difficult emotions. Subscales assessed difficulties with emotional awareness, impulse control, and engaging in goal-directed behavior.

  10. Attitudes toward Mindfulness Training: Change Over Time [0, 3-4, 6-7, and 9-10 weeks]

    Four items developed for the current evaluation were used to assess perceived acceptability and utility of mindfulness training.

  11. Overall Health: Change Over Time [0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up]

    A single item was used to assess self-rated health.

  12. Indiscipline: Occurrence Over Time [3-4, 6-7, and 9-10 weeks]

    Seven items developed for the current evaluation were used to assess behaviors that reflect indiscipline and consequences experienced as a result of indiscipline.

  13. Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time [3-4, 6-7, and 9-10 weeks]

    Eleven items developed for this evaluation were used to assess satisfaction with yoga intervention and preparatory and recovery drills.

  14. Unit Cohesion: Change Over Time [3-4, 6-7, and 9-10 weeks]

    A validated three-item measure was used to assess unit cohesion.

  15. Self-Reported Medical Visits: Occurrence Over Time [0, 3-4, 6-7, and 9-10 weeks]

    A single item measure developed for this evaluation was used to assess frequency of medical visits.

  16. Self-Reported Pain: Change Over Time [0, 3-4, 6-7, and 9-10 weeks]

    Three items were developed for this evaluation assessing the frequency of pain, level of pain, and chronicity of pain.

  17. Impact of Injury on Training: Change Over Time [3-4, 6-7, and 9-10 weeks]

    Eight items developed for the present evaluation were used to assess disruption in training due to injury, trainee response to injury, and outcomes associated with experience of injury.

  18. Use of Mindfulness following Training [6-12 month follow-up]

    Twenty-five items were developed for the present evaluation to assess use of mindfulness and attitudes towards mindfulness practice following basic combat training.

  19. Use of Yoga or Preparatory and Recovery Drills (PRT) following Training [6-12 month follow-up]

    Twenty-three items were developed for the present evaluation to assess use of yoga/PRT drills and attitudes towards yoga/PRT drills following basic combat training.

  20. Use of Mindfulness and Yoga Resources following Training [6-12 month follow-up]

    Nine items were developed for this evaluation to assess receipt and use of mindfulness and yoga resources following training.

  21. Use of Mindfulness during Training: Change Over Time [3-4 weeks; 9-10 weeks]

    Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training.

  22. Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time [3-4 weeks; 9-10 weeks]

    Six items were developed for this evaluation to assess trainees' perception of drill sergeant support for MBAT during basic combat training.

  23. Drill Sergeant Leadership: Change Over Time [3-4 weeks; 9-10 weeks]

    Nine items were used to assess participants' perceptions of the quality of drill sergeant's leadership and instruction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • U.S. Army soldiers participating in basic combat training from OCT - DEC 2020 at a U.S. Army installation in the southeastern United States.
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fort Jackson Fort Jackson South Carolina United States 29702

Sponsors and Collaborators

  • Walter Reed Army Institute of Research (WRAIR)
  • U.S. Army Medical Research and Development Command
  • U.S. Army Training and Doctrine Command (TRADOC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT05550610
Other Study ID Numbers:
  • WRAIR #2815
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Walter Reed Army Institute of Research (WRAIR)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022